Glucagon Emergency Kit for Low Blood Sugar, 1mg recall — Lupin Pharmaceuticals Inc. (Class II)
Lupin Pharmaceuticals Inc. is recorded by the U.S. Food and Drug Administration (FDA) as recalling Glucagon Emergency Kit for Low Blood Sugar, 1mg — a Class II recall, initiated 2026-06-23 and posted to the FDA enforcement report on 2026-07-08, under recall number D-0723-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.”. From the product description, the form is for injection, the strengths given are 1mg and 1 mL and it is marked Rx only. 1 National Drug Code number is printed in the record: 70748-311-01. Distribution is recorded as “Nationwide within the U.S” — Nationwide (US), with the recalling firm on record in FL, United States. It is the only recall number the FDA has filed under event ID 99296. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0723-2026 |
|---|---|
| FDA event ID | 99296 |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Recall initiated | 2026-06-23 |
| Reported by FDA | 2026-07-08 |
| Report lag | 15 days from initiation to report |
| Distribution | Nationwide within the U.S. — Nationwide (US) |
| Firm location on record | FL, United States |
| Product description (source) | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01 |
Reason reported by FDA
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
17 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.
Product identifiers in this record
8 identifying values matched by exact pattern in the 40-word product description above; each is a literal substring of it.
| Product named | Glucagon Emergency Kit for Low Blood Sugar |
|---|---|
| Form | for Injection · Kit |
| Strength | 1mg · 1 mL |
| NDC | 70748-311-01 |
| Marketing category | Rx only |
| Manufactured by | Lupin Limited, Nagpur - 441108 |
| Manufactured for | Lupin Pharmaceuticals, Inc. |
Other indexed recalls from Lupin Pharmaceuticals Inc.
3 indexed records name Lupin Pharmaceuticals Inc. as the recalling firm, across 3 FDA events, reported 2026-05-27 to 2026-07-08. A coverage-limited activity count over the ingested window, not a quality rating.
| Recall record | Recall number | FDA tier | Strength / form | Reported |
|---|---|---|---|---|
| prednisoLONE Acetate Ophthalmic Suspension, 1% | D-0655-2026 | Class II | 1% · Ophthalmic Suspension | 2026-07-08 |
| Liraglutide Injection, 18 mg/3 mL | D-0541-2026 | Class II | 18 mg/3 mL · Injection | 2026-05-27 |
Reported in the same month (2026-07)
111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| BD ChloraPrep Hi-Lite Orange, 2% | D-0643-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
| BD PurPrep, 8.3% | D-0644-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
| BD ChloraPrep Clear, 2% | D-0645-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
| ChloraPrep FREPP, 2% | D-0646-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
| BD ChloraPrep Hi-Lite Orange, 2% | D-0647-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
| BD ChloraPrep Hi-Lite Orange, 2% | D-0648-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
| BD ChloraPrep Scrub Teal, 2% | D-0649-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
| BD ChloraPrep Scrub Teal, 2% | D-0650-2026 | Carefusion 213, LLC | Class II | 2026-07-08 |
Nearest Class II recalls by date
213 of 250 indexed records share the Class II tier; the 6 nearest to 2026-07-08 by report date are listed here.
| Recall record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| BD ChloraPrep CLear, 2% | D-0651-2026 | Carefusion 213, LLC | 2% · Solution | 2026-07-08 |
| BD ChloraPrep CLear, 2% | D-0652-2026 | Carefusion 213, LLC | 2% · Solution | 2026-07-08 |
| IMULDOSA, 130 mg/26 mL | D-0653-2026 | Accord Biopharma Inc | 130 mg/26 mL · Injection | 2026-07-08 |
| Levothyroxine Sodium Tablets, 300 mcg | D-0656-2026 | Accord Healthcare, Inc. | 300 mcg · Tablets | 2026-07-08 |
| Synjardy XR Tablets, 1000 mg | D-0657-2026 | Boehringer Ingelheim Pharmaceuticals, Inc. | 1000 mg · Extended-Release Tablets | 2026-07-08 |
| Accucaine, 1% | D-0658-2026 | Asclemed Usa Inc. | 1% · Injection | 2026-07-08 |
Reading this record
Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. Match a package against 70748-311-01 at the FDA source to confirm it is covered.
Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Lupin Pharmaceuticals Inc. (5 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0723-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0723-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-07-08
- Ingested
- 2026-08-22
- Record hash
4d9c7781babf6915
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.