CLASS II Drug recall · Reported 9 Mar 2016 · FDA Enforcement Report
Alendronate Sodium Tablets, USP, 70 mg* blisters recalled
Sun Pharma Global Fze is recalling Alendronate Sodium Tablets, USP, 70 mg* blisters per, distributed nationwide in the US. The recall was initiated on 11 Feb 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0735-2016
- FDA event ID
- 73420
- Recalling firm
- Sun Pharma Global Fze, Sharm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Feb 2016
- FDA classified
- 3 Mar 2016
- Reported
- 9 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 11 Feb 2016 | Recall initiated by company | |
| 3 Mar 2016 | Classified by FDA | +21 days |
| 9 Mar 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Which lots are affected?
Lot #s: JKP2234A, JKP2235A, Exp 04/17
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sun Pharma Global Fze
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | buPROPion Hydrochloride Extended-¿release Tablets USP (SR) recalledBupropion Hydrochloride | Sun Pharma Global Fze | Potency & Assay | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled | Sun Pharma Global Fze | Particulate Matter | Nationwide |
| Drug | CLASS II | Levetiracetam, extended release tablets, 750 mg recalled | Sun Pharma Global Fze | Potency & Assay | Nationwide |
Other Alendronate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |